Nctid:
NCT06226038
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>10}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2025-01-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-05", "completionDateStruct"=>{"date"=>"2026-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-05-13", "studyFirstSubmitDate"=>"2024-01-17", "studyFirstSubmitQcDate"=>"2024-01-17", "lastUpdatePostDateStruct"=>{"date"=>"2024-05-16", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Implant stability quotient", "timeFrame"=>"90 days", "description"=>"Stability quantity of dental implant measured by resonance frequency analysis machine"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Static magnetic field", "Dental implant", "Bone healing"], "conditions"=>["Implant Site Reaction"]}, "descriptionModule"=>{"briefSummary"=>"To evaluate the effect of static magnetic field on dental implant to bone integration.", "detailedDescription"=>"Bone to implant integration depend on bone healing. Magnetic field was proved to promote and make bone to implant integration happen faster. We decided to investigate by placing 2 dental implants in lower jaw of complete edentulous patients with specialised temporary dentures. Said denture will have neodymium magnet on one side, completely embedded in acrylic mass."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* healthy, complete edentulous area\n\nExclusion Criteria:\n\n* uncontrolled NCDs patients"}, "identificationModule"=>{"nctId"=>"NCT06226038", "briefTitle"=>"Effect of Static Magnetic Field on Dental Implant Stability.", "organization"=>{"class"=>"OTHER", "fullName"=>"Mahidol University"}, "officialTitle"=>"Effect of the Modified Magnetic Interim Denture on Dental Implant Stability and Marginal Bone Level: a Double-blind Randomized Controlled Trial Study", "orgStudyIdInfo"=>{"id"=>"COA. MURA2023/919"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"With magnet", "interventionNames"=>["Other: Magnet disc"]}, {"type"=>"SHAM_COMPARATOR", "label"=>"Without magnet", "interventionNames"=>["Other: Stainless steel"]}], "interventions"=>[{"name"=>"Magnet disc", "type"=>"OTHER", "description"=>"Magnetic field promote proliferation and stimulate osteoblast differentiation", "armGroupLabels"=>["With magnet"]}, {"name"=>"Stainless steel", "type"=>"OTHER", "description"=>"For control", "armGroupLabels"=>["Without magnet"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"10400", "city"=>"Bangkok", "state"=>"Payatai", "status"=>"RECRUITING", "country"=>"Thailand", "contacts"=>[{"name"=>"Chayapong Supachatwong, PhD.", "role"=>"CONTACT", "email"=>"chayapong.sup@mahidol.ac.th", "phone"=>"+66909780204"}, {"name"=>"Chayapong Supachatwong, PhD.", "role"=>"CONTACT"}], "facility"=>"Mahidol university", "geoPoint"=>{"lat"=>13.75398, "lon"=>100.50144}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Mahidol University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
